Comprehensive Cardiac Structure-Function Analysis in Heart Transplantation

心脏移植中全面的心脏结构功能分析

• 批准号: 8797337
• 负责人: James Carr
• 金额: $ 59.67万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-02-04 至 2019-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8797337
• 关键词: Acute; Allografting; Ambulatory Care Facilities; Angiography; Area; Biopsy; Blood Vessels; Cardiac; Caring; Catheters; Cause of Death; Clinical; Clinical Research; Coronary; Coronary Angiography; Cost Effectiveness Analysis; Cost utility; Coupled; Data; Decision Modeling; Decision Trees; Detection; Diagnostic; Diagnostic tests; Diffuse; Disease; Early Diagnosis; Echocardiography; Edema; Evaluation; Event; Fibrosis; Functional disorder; Goals; Gold; Health; Healthcare; Heart; Heart Transplantation; Impairment; Individual; Left; Life; Longitudinal Studies; Magnetic Resonance Imaging; Maps; Modality; Modeling; Monitor; Myocardial; Nature; Operative Surgical Procedures; Outcome; Patient Monitoring; Patients; Perfusion; Phase; Procedures; Protocols documentation; Quality of life; Reference Standards; Resources; Risk; Risk Factors; Risk Marker; Sampling Errors; Sensitivity and Specificity; Structure; Techniques; Testing; Thick; Time; Tissues; Transplant Recipients; Transplantation; Ultrasonography; Vascular Diseases; Visit; base; comparative; cost; cost effectiveness; extracellular; follow-up; heart allograft; imaging modality; improved; markov model; mortality; non-invasive imaging; novel; two-arm study

DESCRIPTION (provided by applicant): Heart transplant (Tx) surgery is a well-established life-saving procedure, but is associated with post- interventional risks such as acute cardiac rejection (ACR) which is one of the leading causes of death in the first year after transplant. Beyond the first year, cardiac allograft vasculopathy (CAV) is the single greatest risk factor for 5-year mortality. Monitoring the patient for post-transplant events is thus paramount. The standard monitoring strategy, however, relies on frequent (12-16 monitoring nodes during year 1 alone) invasive and costly procedures including endomyocardial biopsies (EMB) and catheter angiography. Since EMB and catheter angiography have limited sensitivity due to sampling errors (ACR) or the diffuse nature of the disease (CAV), a reliable non-invasive alternative for the early detection of ACR and CAV would be desirable to reduce the need for invasive procedures, improve sensitivity, and reduce cost. We have recently developed and applied cardiac MRI techniques for the non-invasive assessment of myocardial edema (T2-mapping), diffuse fibrosis (pre- and post-contrast T1-mapping), myocardial velocities (tissue phase mapping), and microvascular quantitative perfusion. We have shown that these techniques can identify distinct regional structural and functional alterations in the heart that correlate with te status of the allograft. Based on these findings, a detailed cost-effective analysis using Markov modeling and decision tree analysis has demonstrated that cardiac MR has tremendous potential to reduce monitoring costs by 40-50% during the first year after Tx alone. This proposal builds on these promising findings and our aim is to develop an new 15-minute structure-function cardiac MRI protocol for the improved detection regional abnormalities associated with ACR (edema, fibrosis, dysfunction) and CAV (perfusion, dysfunction). Integration of MRI with echocardiography and intravascular Ultrasound (IVUS) will provide unique multi-modality assessment of the allograft. The application in a longitudinal clinical study coupled with state-of-the-art cost-effectiveness analysis will allow redefining the most effective post-Tx mixed monitoring strategy. The aim is to to help clinicians identify the optimal mixed monitoring strategy, i.e. the optimal combination of multi-modality imaging (structure-function MRI, echo, IVUS) and invasive procedures (EMB, catheter angiography) which provide best outcome (quality adjusted life days) and lowest cost for the individual cardiac transplant patient.

描述（由申请人提供）：心脏移植（TX）手术是一种良好的挽救生命的程序，但与诸如急性心脏抑制（ACR）之类的介入后风险相关，这是移植后第一年的主要死亡原因之一。除了第一年，心脏同种异体移植血管病（CAV）是5年死亡率的最大风险因素。因此，监测患者的移植后事件至关重要。然而，标准监测策略依赖于频繁的（仅在第一年就在12-16个监测节点）侵入性和昂贵的程序，包括内膜活检（EMB）和导管血管造影。由于由于采样误差（ACR）或疾病的弥漫性（CAV），EMB和导管血管造影的灵敏度有限，因此需要可靠的非侵入性替代方法来早日检测到ACR和CAV，以减少对侵入性手术的需求，提高敏感性并降低成本。我们最近开发并应用了心脏MRI技术，用于对心肌水肿（T2映射），弥漫性纤维化（前后和对比后T1映射），心肌速度（组织相位映射）和微血管定量灌注的非侵入性评估。我们已经表明，这些技术可以识别与同种异体移植状态相关的心脏中不同的区域结构和功能改变。基于这些发现，使用马尔可夫建模和决策树分析进行了详细的具有成本效益的分析，表明心脏MR在仅在TX之后的第一年将监视成本降低40-50％具有巨大的潜力。该提案建立在这些有希望的发现的基础上，我们的目的是为改进与ACR（水肿，纤维化，功能障碍）和CAV（灌注，功能障碍）相关的改进的检测区域异常开发新的15分钟结构功能MRI方案。 MRI与超声心动图和血管内超声（IVU）的整合将提供同种异体移植的独特多模式评估。纵向临床研究中的应用 再加上最先进的成本效益分析将允许重新定义最有效的TX混合监控策略。目的是帮助临床医生确定最佳的混合监测策略，即多模式成像（结构功能MRI，ECHO，IVUS）和入侵程序（EMB，导管血管造影）的最佳组合，这些程序可提供最佳结果（质量调整的寿命）和单个心脏移植患者的最低成本。